CN103338711A

CN103338711A - Device and method for fixating a suture anchor with a suture or a headed anchor in hard tissue

Info

Publication number: CN103338711A
Application number: CN2012800064854A
Authority: CN
Inventors: J·迈尔; M·莱曼
Original assignee: Sportwelding GmbH
Current assignee: Sportwelding GmbH
Priority date: 2011-01-28
Filing date: 2012-01-26
Publication date: 2013-10-02
Anticipated expiration: 2032-01-26
Also published as: US20120197316A1; EP3632341B1; CN103338711B; US20140364908A1; BR112013019027A2; KR101998429B1; KR20140006882A; EP2667789B1; JP2014510554A; EP2667789A1; US9808235B2; IL227074A; CA2821360A1; EP3632341A1; RU2602326C2; WO2012100358A1; RU2013138870A; CA2821360C; US8834542B2; JP6120776B2

Abstract

Device and method as disclosed are suitable for fixating soft tissue to hard tissue with the aid of a suture anchor (2) and a suture (4) or with the aid of a headed anchor, wherein the anchor (2) is forced into the hard tissue (forcing step) and then anchored therein (anchoring step) by in situ liquefaction of a material having thermoplastic properties. The device comprises a vibration tool (1) and the anchor (2) and possibly a support element (80), wherein the anchor (2) comprises an anchor foot (22) and a thermoplastic sleeve (23). The thermoplastic sleeve (23) comprises the material having thermoplastic properties. The anchor foot (22) has a distal end suitable for being forced into hard tissue and it is connected to the distal end of the vibration tool (1) and the thermoplastic sleeve (23) sits on a proximal face of the anchor foot (22), the vibration tool and/or a proximal portion of the anchor foot extending into or through the thermoplastic sleeve. The connection between the tool (1) and the anchor foot (22) is equipped for not only transmitting vibration from the tool to the anchor foot but also for transmitting a compressive and a tensile force. Through this measure the anchor (2) can be forced into the hard tissue by applying the compressive force and vibration to the tool (1) and can be anchored in the hard tissue by liquefaction of the sleeve material by applying the tensile force and vibration to the tool (1), i.e. the two steps of the fixation process is carried out using the same tool and without displacing the tool between the two steps.

Description

Be used for to have sutural suture anchor or having an anchor to be fixed to equipment and the method for sclerous tissues

Technical field

The invention belongs to field of medical technology, and relate to a kind of for having sutural suture anchor or having head to be anchored on equipment and the method for sclerous tissues, be used for especially by means of stitching thread or have an anchor that soft tissue is attached to sclerous tissues, wherein said sclerous tissues is the osseous tissue of the mankind or animal patient in particular, but also can be for example to strengthen osseous tissue or bone alternate material.

Background technology

Open text WO2009/109057(Woodwelding) a kind of equipment and method that stitching thread is attached to sclerous tissues by means of suture anchor disclosed, wherein said suture anchor comprises material with thermoplastic properties and is anchored in sclerous tissues's opening by means of vibrational energy that described vibrational energy is used for having the original position liquefaction of thermoplastic properties material.The material of liquefaction penetrates in the hole or other suitable structures of sclerous tissues in sclerous tissues's opening.Disclosed equipment comprises vibration source, vibration tool, guide wire, anchor, stitching thread and the possible promotion sleeve pipe in the housing in specified open text.The near-end of vibration tool is coupled to vibration source, and the near-end of guide wire is supported on the housing, and anchor is arranged in the far-end of vibration tool.Described anchor comprises the material with thermoplastic properties, and it is with the form of thermoplasticity sleeve, and described anchor or described vibration tool are by described sleeve, and described sleeve is sandwiched between the runners and vibration tool, guide wire or promotion sleeve pipe of anchor.Suture loop remains in the runners of anchor, two stitching thread end portion extend through the more distal part of anchor and pass vibration tool and the each several part of guide wire, they from the there leave, with keep possibly by being attached to guide wire or housing or stitching thread management system straight line or the tension.

In order to implant, opening is provided in sclerous tissues, and the far-end of equipment or suture anchor is introduced into respectively in this opening, so that at least part of thermoplasticity sleeve is positioned in this opening, the cross section of wherein said opening is less times greater than the cross section of thermoplasticity sleeve, be positioned near the sclerous tissues of wall of described opening so that have the material of thermoplastic properties, but make when being introduced into this anchor in the described opening, not friction between the wall of described sleeve and described opening.Activate vibration source then, and the material with thermoplastic properties that is clamped in the thermoplasticity sleeve between vibrating elements (vibration tool or be coupled to the spud of vibration tool) and the opposition element (be not coupled to spud, the guide wire of vibration tool or promote sleeve pipe) begins liquefaction from its proximal face and/or distal surface, and flow in the sclerous tissues, and then the thermoplasticity sleeve becomes shorter.Keep the chucking power to the thermoplasticity sleeve more in short-term in order to become at the thermoplasticity sleeve, equipment component is motion relative to each other in the axial direction, this preferably is subjected to the influence of pretension spring, and described pretension spring is arranged with the thermoplasticity sleeve and with each element that the thermoplasticity sleeve is clamped in the enclosed load framework at least.This measure allows the automatic anchoring of suture anchor, and the surgeon only needs the far-end by guide wire to make this equipment be positioned on the surface of sclerous tissues and activates vibration source.Yet, need certain measures to come inspection and the adjusting of this equipment before allowing the anchoring program under the situation of the liquefaction that need not the thermoplasticity bush material.

Open text US2009/131947(Woodwelding) also disclose and a kind ofly by means of suture anchor stitching thread is attached to the method for sclerous tissues, wherein said suture anchor comprises by means of vibrational energy the thermoplastic that liquefied by original position.Disclosed method is based on the principle identical with the top method of sketching, wherein stitching thread passes the distal portion of anchor, wherein the close end of anchor comprises thermoplastic, and wherein the proximal side of anchor keeps the distal face of butt vibration tool by tractive stitching thread terminal part on proximal direction.

Text US-7678134 is being disclosed additive method and the equipment that stitching thread is attached to sclerous tissues by means of suture anchor, US-7695495, US-2006/161159, US-2009/192546, US-2009/187216 (all belonging to Arthrex), US-5733307 (Dinsdale), or it is open among the US-6508830 (Steiner), wherein disclosed anchor comprises extrusion screw or the preferred connector of being made by bone material that is screwed into for the bone opening of this purpose, connector is press-fitted in the bone opening for this purpose, and wherein said stitching thread is kept by screw or connector, or keep by the other element that remains on by means of described screw or connector in the opening.

By means of the material with thermoplastic properties that the method in the anchoring articles opening in being arranged at sclerous tissues, in for example mankind or the animal patient osseous tissue is open in open text US-7335205, US-7008226, US-2006/0105295, US-2008/109080, US-2009/131947, WO-2009/109057 and WO-2009/132472, described material with thermoplastic properties is by original position liquefaction and can permeate the sclerous tissues of described perforated wall.All these specify the full content of open text and application to be contained in this by reference.

Summary of the invention

Generally speaking, the objective of the invention is to produce a kind of for having sutural suture anchor or having head to be anchored on additive method and other equipment of the sclerous tissues of the mankind or animal patient, wherein be fixed on stitching thread in the sclerous tissues by means of suture anchor, or there is an anchor to be particularly suitable for soft tissue is attached to sclerous tissues, wherein said sclerous tissues is osseous tissue in particular, but also can be for example to strengthen osseous tissue or bone alternate material, and wherein in this method step comprises the original position liquefaction of the material with thermoplastic properties, and make liquefied material contact with sclerous tissues.Suture anchor or (trabecularism of tissue or be provided for anchoring, preferred otch chamber especially) arranged an anchor to penetrate into by liquefied material to be fixed in sclerous tissues's wall of opening in sclerous tissues's opening, or exceed opening by liquefied material expansion and exceed sclerous tissues's opening and fix, namely be fixed on the noncontact side of sclerous tissues's layer, possibly in conjunction with permeating this sclerous tissues surface with this noncontact side at sclerous tissues's layer.During resolidification, the material that penetrates in the sclerous tissues constitutes being connected fully between sclerous tissues and the anchor; During resolidification, the material formation that extends beyond sclerous tissues's opening can not be by the main body of opening.The improvement that realizes by the present invention compared with prior art, the method and apparatus that is used for identical purpose relates to simplification and/or stitching thread or the suture anchor of method and apparatus especially or an anchor is arranged at the constant intensity of sclerous tissues.

The objective of the invention is to produce a kind of for suture anchor or have head to be anchored on sclerous tissues's opening or exceed sclerous tissues's opening fixing other equipment and additive method, wherein anchor is anchored in the opening by means of the material with thermoplastic properties, described material is liquefied by original position and contacts with sclerous tissues, permeate the sclerous tissues of the wall of sclerous tissues's opening especially, and wherein can realize providing the step of sclerous tissues's opening or its part and by means of the step of identical apparatus anchoring anchor and need not between these two steps apparatus to be removed from fixed position.Apparatus and method according to the invention also is suitable for Minimally Invasive Surgery especially, but also can be applicable in the open surgical procedures.

Above-mentioned purpose realizes by equipment and the method that limits as independent claims.

According to the present invention, suture anchor or have an anchor to comprise far-end, its assembling is used for not ordered about to enter in the sclerous tissues fully under sclerous tissues provides the situation of opening.Described anchor is ordered about in initial application of force step and is entered in the sclerous tissues, fix by means of having thermoplastic properties and being liquefied to be fixed in the opening or to exceed opening with the material that contacts with sclerous tissues by original position then, permeate sclerous tissues's (anchoring step) of perforated wall in particular.The vibration tool of in the anchoring program, using wherein, the vibration tool of original position liquefaction that namely is used for having the material of thermoplastic properties also is used for ordering about anchor and enters sclerous tissues, and wherein said ordering about preferably strengthened by vibration.

Described anchor comprises spud and is seated on the spud and comprises the thermoplasticity sleeve of the material with thermoplastic properties.Described vibration tool and/or spud extend through the thermoplasticity sleeve, and the distal attachment of vibration tool is to spud.Vibration tool and to the connection of spud designed to be able to the required power (traction force) of the power that application of force step is required (propulsive force) and anchoring step and preferably at the transfer of vibration of these two steps to spud.Therefore described instrument transmits the mode of compression stress and tension force and mechanical vibration and is convenient to be attached to spud from the mode that spud separates after finishing in these two step process (application of force step and anchoring step) being suitable for.

For application of force step with for the anchoring step, vibration tool is coupled to vibration source, the supersonic vibration source (for example in particular, piezoelectric vibra, it may comprise the supercharger of this instrument that is coupled), and the assembly of instrument and spud (or anchor) is suitable for vibration is passed to spud or anchor from its nearside tool ends end, is preferably so that nearside anchor face is with the vertical amplitude vibrations of maximum.The material arrangements that will be liquefied in the anchoring step is near this vibration anchor face.Can also activate described instrument come radially or direction of rotation vibrate.

By means of the vibrational energy of being combined with the thermic load accepted of tissue and the suitable mechanical character that is connected fully that produces, suitable original position liquefaction with material of thermoplastic properties is to have the material of thermoplastic properties also in conjunction with being preferably at 2kHz to (being preferably 15kHz between the 40kHz between the 200kHz by use, or even be more preferably at 20kHz between the 30kHz, perhaps at the liquefaction that directly contacts with vibration tool at 25kHz between the 35kHz) frequency of vibration realize that this material has the initial elasticity modulus of 0.5GPa at least and up to about 350 ℃ fusion temperature.Be used to transmitting vibrations and do not lose mechanical stiffness if having the material of thermoplastic properties, then the elastic modelling quantity of 0.5GPa is special needs at least.If the material with thermoplastic properties is transmitting vibrations but be liquefied in the direct place of contact vibration instrument not, if perhaps have the material transfer vibration of thermoplastic properties but supported and guiding by the part of appliance of other materials, the material that then has thermoplastic properties can have smaller elastic modelling quantity.

At the anchoring step, preferably export work with substantially invariable oscillation power, i.e. vibration (vibration of foundation) with substantially invariable frequency and amplitude comes work, wherein said frequency is in the said frequencies scope and be the resonant frequency of vibrational system, and wherein said amplitude is preferably 20 to 40 μ m in the scope of 10 to 50 μ m.At application of force step, constitute under the situation of relative high-drag in sclerous tissues especially, preferably the vibration mode of learning from the auxiliary bone cutting of for example vibration.The pulse that this vibration mode generally includes high amplitude more and profile that may be more sharp-pointed (for example, rectangular profile or Dirac pulse), and for example the amplitude by the modulation vibration of foundation for example forms more that the pulse of high amplitude provides, and sharpening input waveform and provide by the matching system resonant frequency by comparing the vibration of foundation also preferably.So the pulse of creating can comprise one or more vibration of foundation waveform cycle, and can be periodic, it has the modulating frequency that is preferably in the 0.5-5kHz scope, or they can be generated (on amplitude and modulating frequency) randomly, but all the resonant frequency phase place with system is consistent in any case.Means for generation of the pulse that takes place are at random for example described in open text US7172420 (St.Imier).Wherein the more high amplitude of pulse is preferably more than vibration of foundation amplitude and multiply by the factor between one 2 and 10.

Alternately, this pulse can realize by the stack vibration of foundation or by it being replaced with the pulse excitation that is produced by mechanical pulsing generator (for example, comprising uneven piece or the hammer that rotation drives).Wherein the more high amplitude of pulse is preferably more than vibration of foundation amplitude again and multiply by the factor between 2 and 10, and pulse frequency regulates and is lower than especially the lowest resonance frequency (for example, the not expectation curve formula of supersonic generator vibration) of vibrational system in can the zone between 20 to 200Hz.If may carry out material liquefaction but preferably can stop material liquefaction during application of force step, then low pulse frequency is particular importance.

If two different vibration modes are used for the application of force and anchoring step as mentioned above, then the vibration source that is coupled during two steps of vibration tool is assembled optionally to produce this two kinds of vibration modes, and has conversion equipment to be used for that vibration source is converted to another vibration mode from a kind of vibration mode.

The material with thermoplastic properties that is suitable for the thermoplasticity sleeve of apparatus and method according to the invention is thermoplastic polymer, for example: can absorb or degradable polymer, such as based on the polymer (PLA, PLLA, PGA, PLGA etc.) of lactic acid and/or glycolic or polyhydroxyalkanoate (PHA), polycaprolactone (PCL), polysaccharide, poly-dioxane (PD), poly-anhydride, polypeptide or corresponding copolymer or comprise above-mentioned polymer as the composite of constituent; Perhaps can not absorb or nondegradable polymer, such as polyolefin (for example polyethylene), polyacrylate, polymethylacrylic acid, Merlon, polyamide, polyester, polyurethane, polysulfones, poly-aryl ketones, polyimides, polyphenylene thioether or liquid crystal polymer (LCP), polyacetals, halogenated polymer, especially halogenated polyolefin, halo polyphenylene thioether, halo polysulfones, halogenated polyether or equivalent copolymer or comprise above-mentioned polymer as the composite of constituent.

The specific embodiment of degradation material is polylactic acid such as LR706PLDLLA70/30, R208PLDLA50/50, L210S and PLLA100%L for example, and it is the product of Bohringer.The tabulation of suitable degradable polymer material is also shown in " Medizinaltechnik mit biokompatiblen Materialien und Verfahren " the 3rd edition (being designated hereinafter simply as " Wintermantel ") the 200th page that the Erich Wintermantel that published at Berlin Springer Verlag in 2002 and Suk-Woo Haa show; About the content of PGA and PLA referring to the 202nd page; About the content of PCL referring to the 207th page; About the content of PHB/PHV copolymer referring to the 206th page; About the content of poly-dioxanone PDS referring to the 209th page.Can for example see people's such as CA Bailey J Hand Surg[Br about the discussion of bioabsorbable material] 2006Apr; 31 (2): 208-12.

The specific embodiment of non-degradable material has: polyether-ketone (PEEK Optima, Grades450 and 150, the Invibio company limited), Polyetherimide, polyamide 12, polyamide 11, polyamide 6, polyamide 66, Merlon, polymethyl methacrylate, polyformaldehyde or polycarbonate polyurethane (for example Bionate series, particularly 65D and the 75D of DSM).The general introduction form of polymer and its application is listed in the 150th page of Wintermantel; Concrete example is found in the 161st page of (PE of Wintermantel, Hostalen Gur812, Hoechst company), the 164th page (PET), the 169th page of (PA, be PA6 and PA66), the 171st page (PTFE), the 173rd page (PMMA), the 180th page (PUR is referring to form), the 186th page (PEEK), the 189th page (PSU), the 191st page (POM-polyformaldehyde, brand name are Delrin, Tenac also is used for endoprosthesis by Protec).

Material with thermoplastic properties also can comprise exotic phase or the chemical compound that is used as other function.Especially, this thermoplastic can be strengthened and formed composite thus by composite fibre or (for example calcium phosphate ceramic or glass) whisker.But the original position that also can comprise this material with thermoplastic properties expands or the component (for example polyester, polysaccharide, hydrogel, sodium phosphate) of dissolving (generation hole) but, make implant become opaque and it is discharged by the visible chemical compound of X ray or original position and have chemical compound (for example, inflammation inhibitor or the alleviant such as sodium phosphate or calcium carbonate of the adverse effect of somatomedin, antibiotic, opposing acid decomposition) as the therapeutic effect that promotes healing and regeneration.If thermoplastic is can be resorbent, then the release of described chemical compound will be delayed.

Employed filler can comprise that the degradable bony spur for degradable polymer swashs filler, comprise: the mixture of bata-tricalcium phosphate (TCP), hydroxyapatite (HA, degree of crystallinity is less than 90%) or TCP, HA, DHCP, bio-vitric (seeing Wintermantel).Only the bone of part degraded or degraded is hardly integrated stimulates filler to comprise for non-degradation polymer: bio-vitric, hydroxyapatite (degree of crystallinity is greater than 90%),

, referring to: people's such as SM Rea J Mater Sci Mater Med.2004Sept; 15 (9): 997-1005; Be also shown in for hydroxyapatite: people's such as L.Fang Biomaterials2006Jul; 27 (20): 3701-7; People's such as M.Huang J Mater Sci Mater Med2003Jul; 14 (7): 655-60; And the Materials World1997Jan of W.Bonfield and E.Tanner; 5no.1:18-20.The embodiment of biological active filling material and discussion thereof for example can see: the J Biomater App.2007Apr of X.Huang and X.Miao; 21 (4): 351-74; People's such as JA Juhasz Biomaterials, 2004Mar; 25 (6): 949-55.The particulate filler type comprises: thick type: 5-20 μ m (its content is preferably the volume ratio of 10-25%), and submicron (Nano filling obtains by separating out, and preferably its tabular length-width ratio is greater than 10, and diameter is 10-50nm, and content is the volume ratio of 0.5-5%).Experiment shows, fills thermoplastic polymer by the liquefaction permission of ultrasonic vibrational energy with high relatively degree, and can not weaken the ability that liquefied material penetrates into structure (trabecularism of the spongy bone of for example living).

Anchor except thermoplasticity sleeve part can be made up of any suitable material (for example, polymer, metal, pottery, glass), and these materials can be biological absorbable or abiotic absorbable and be liquable or not liquefiable.Abiotic absorb or abiotic degradation material can be included in osseous tissue contact position assembling and is used for promoting surface that bone integrates (for example, known surface texture or coating itself), especially the material of thermoplasticity sleeve be biology can absorb or biodegradable and therefore the anchoring function need be integrated when replacing gradually by bone.Utilization is by the polylactic acid (PLA) of filling hydroxyapatite or calcium phosphate, especially fill the PLLA (Poly-L-lactic acid) of 60% tricalcium phosphate or fill spud that the PDLLA (PDLLA) 70%/30% (70%L and 30%D/L) of 30% liang of calcium phosphate phase makes and be combined with the thermoplasticity sleeve of being made by PLDLLA (gathering left-handed/racemic lactic acid) 70%/30% (70%L and 30%D/L) and obtained good result, the LR706 that described thermoplasticity sleeve is buied from Bohringer company in this way.PDLLA70%/30% of filling 30% liang of calcium phosphate phase and similar material turns out to be and also is suitable for the thermoplasticity sleeve and therefore is suitable for making the biological absorbable integral type anchor of only being made by a kind of material.

Assembling need comprise the material that has based on the corresponding mechanical strength of ordering about the mechanical resistance of expecting in the sclerous tissues that anchor enters with the far-end that is used for being ordered about the spud that enters sclerous tissues or anchor.If this resistance higher relatively (order about and pass cortical bone or hard and fine and close spongy bone), then the far-end of anchor for example comprises such as the metal of titanium or titanium alloy, such as sintered calcium phosphate (for example, hydroxyapatite) or engineering ceramics (for example, zirconium oxide, aluminium oxide) ceramic material or PEEK or similar heat-resistant polymer, and other anchors part is for example made by Biocomposite material, a kind of in the polylactic acid of all fillings as mentioned above or top mentioned other thermoplastic polymers.Alternately, this far-end of anchor can comprise coating hard and that may grind, and it is for example by calcium phosphate or the plasma spraying formation of deposits of titanium valve on PEEK or polylactic acid or Biocomposite material.If above-mentioned resistance less (order about and enter in the spongy bone), the far-end of spud can be formed and even can be made up of the same material with thermoplastic properties identical with the thermoplasticity sleeve by less material.In latter's situation, this material in addition can during the application of force step on the surface of distally anchor end by partial liquefaction.This liquefaction can remain in the allowable limit in following situation, i.e. (a) vibration of be used for strengthening the application of force have low relatively frequency (＜10kHz), itself in addition only can cause very slow liquefaction at high amplitude, and (b) after application of force step, carry out the anchoring step immediately, namely before anchor end possible liquefied material in distally can lock spud with respect to sclerous tissues.If the mechanical strength that anchor will be ordered about the sclerous tissues that enters a little less than, then condition (b) is not too important.

Because be used for that the instrument of fixation procedure can be designed to be very thin and 200mm is long or even longer, apparatus and method according to the invention is particularly suitable for Minimally Invasive Surgery, but also can be applicable in the open surgical procedures.The assembly of vibration tool and spud or anchor preferably has length corresponding to the multiple of half of vibration wavelength in these tool materials (at the frequency of vibration of the instrument that is made of titanium and spud and 20kHz between near-end and nearside anchor face, this length is preferably n times of 126mm, and n is integer).

For the ease of making, suture anchor or have a ground tackle that circular cross-section is arranged not only, and pass the axial passage of thermoplasticity sleeve and the far-end of vibration tool also will have circular cross-section.Yet this is not at condition of the present invention, any one the had noncircular cross section according to the present invention in the above-mentioned parts, and wherein the cross section of spud is preferably identical with the cross section of thermoplasticity sleeve or less times greater than the cross section of thermoplasticity sleeve.

Apparatus and method according to the invention can be applicable to all surgical operations in the mankind or the animal patient, in described surgical operation, stitching thread need be attached to sclerous tissues, be attached to osseous tissue especially, wherein anchor fixing preferably below the cortical bone layer, realize (be arranged under the cortical bone layer spongy bone or on the inboard of cortical bone layer or fixing under the so-called cortex of the chamber of adjacent bones cortical layer on the cortical bone layer inboard or soft tissue).In an identical manner, apparatus and method according to the invention can be applicable to stitching thread is attached to be had the replacing material (bone alternate material) that is similar to sclerous tissues's feature or is attached to part sclerous tissues part replacing material or possibly even be attached to other implants (for example, endoprosthesis).

The example of these application is:

About foot and ankle: stable, inboard stable, the heel string reparation in the outside or reconstruction, hallux valgus reparation or reconstruction or treatment, arch of foot reparation or reconstruction, sole of the foot ligament repair or reconstruction, toes tendon shift, retinaculum musculorum peroneorum reparation or reconstruction;

About knee joint: medial collateral ligament reparation or reconstruction, lateral collateral ligament reparation or reconstruction, patellar ligament reparation or reconstruction, the ligament repair of retreading or reconstruction, iliotibial tract tenodesis;

About hands and wrist: ligament repair or reconstruction between scapholunatum, ligament at wrist joint reparation or reconstruction, side para-ligament reparation or reconstruction, ulnar collateral ligament reparation or reconstruction, radial collateral ligament reparation or reconstruction, for all fingers shift at the reparation of PIP, DIP and MCP joint flexor tendon and extensor tendon or reconstruction, finger tendon, the joint capsule of metacarpophalangeal joints adheres to again;

About elbow: biceps tendon adheres to again, ulnar side or oar side side para-ligament are repaired or rebuild;

About hip joint: joint capsule reparation or reconstruction, glenoid lip of articulation of hip reparation or reconstruction;

About takeing on: shoulder sleeve reparation or reconstruction, Ban Kate (bankart) reparation or reconstruction, SLAP injury repairing or reconstruction, biceps brachii m. tendon are fixed, acromioclavicular joint separates reparation or reconstruction, triangular muscle reparation or reconstruction, joint capsule displacement or joint capsule reparation or reconstruction;

About pelvis: the female incontinence patient's who causes at per urethram over-activity or internal sphincter functional defect bladder neck suspension;

Perform the operation about structive sursery: the general of joint capsule reparation, the especially ligament in shoulder, hip joint, knee joint, elbow and pawl of the reconstruction of cranium ligamentum cruciatum (the cranium ligamentum cruciatum of Canis familiaris L.), shoulder and hip joint and tendon and bone fixed.

Description of drawings

The present invention is described by reference to the accompanying drawings in further detail, wherein:

Fig. 1 shows the first fixed illustrative embodiments of anchoring according to the present invention, and wherein said fixedly is fixing under the cortex, and at fixing under the described cortex, the thermoplasticity sleeve preferably begins liquefaction from its near-end;

Fig. 2 shows and does not use to provide the method according to Fig. 1 fixing under the cortex;

Fig. 3-6 shows the anchor that is suitable for fixing means illustrated in fig. 1 and 2 and other illustrative embodiments of equipment;

Fig. 7 shows another illustrative embodiments of the method according to this invention, and wherein said anchor is the anchor that has for fixing for example soft tissue, and wherein said thermoplasticity sleeve preferably begins liquefaction at its far-end;

Fig. 8 shows the preferred details of anchor shown in Figure 7;

Fig. 9 shows another illustrative embodiments of the method according to this invention, and wherein said spud is static with respect to osseous tissue during the anchoring step;

Figure 10 shows another illustrative embodiments of the anchor that can be applicable in the method according to this invention.

The specific embodiment

Accompanying drawing 1 to 10 shows according to suture anchor of the present invention or an anchor fixing in sclerous tissues's (being preferably osseous tissue) is arranged, and namely in application of force step and anchoring step, and is suitable for this fixing anchor and equipment.In the anchoring step, the material of anchor by having thermoplastic properties is anchored in the sclerous tissues by means of the original position liquefaction of vibrational energy and by making liquefied material penetrate in the sclerous tissues (trabecular tissue structure, or special arrange, otch chamber preferably) or entering in the chamber on sclerous tissues's noncontact side.In the application of force step before the anchoring step, anchor is ordered about to be entered in the sclerous tissues and then provide opening in sclerous tissues's (or its part) at least, anchor will be anchored in this opening or exceed this opening, wherein at this application of force, and essentially identical instrument in use and the anchoring step.Wherein anchor is ordered about and is entered in the sclerous tissues, and it is preferably by means of the vibrational energy that provides with the employed identical vibration tool of anchoring step.Be used for being described at different application at open text US-2009/131947 according to principle the inventive method and anchoring step as shown in drawings.

Entered in the sclerous tissues in order to order about, anchor or the spud that belongs to the anchor parts are made by the material with suitable mechanical stability respectively, and metal for example is such as titanium or titanium alloy, and its distal face has suitable shape, for example is taper, wedge angle or other shapes.Passed the cortical bone layer in order to order about, spud for example is the shape of bone awl.The distal face of spud can also be assembled into Centesis instrument (referring to Figure 10), is used for the auxiliary puncture of vibration, described at open text WO2008/131884 (Stryker Trauma GmbH).Not too effectively spud only can be ordered about and be entered spongy bone, this means anchor with fixing bone at positioning anchor and order about anchor and rejected or provide the opening that passes the cortical bone layer by cortex before entering bone.The safety location that can also provide pilot hole to be used for anchor in osseous tissue wherein enters and makes pilot hole extended about cross section and/or the degree of depth in the pilot hole by ordering about suture anchor.Can also at first locate the K line and use the K line to order about anchor as guiding then and enter in the sclerous tissues.For this purpose, anchor and at least the far-end of vibration tool need be used for holding the axial passage of K line.

Fig. 1 shows the illustrative embodiments of the present invention with four successive stages (a) to (d) of first illustrative embodiments of the method according to this invention.Wherein suture anchor 2 is fixed on the cancellous bone tissue 8 that is arranged in cortical bone layer 7 below, and the blind hole 5.1 of for example only passing cortical bone layer 8 wherein is provided in advance.Certainly also can realize similar fixing when not having cortical layer, wherein the fixed position will have desired depth and for example be arranged in below the finer and close spongiosa osteoplaque of the spongy bone with less density.Suture anchor 2 is arranged on the far-end of vibration tool 1, and it comprises spud 22(distally anchor parts) and thermoplasticity sleeve 23(nearside anchor parts), wherein thermoplasticity sleeve 23 comprises the material (material with thermoplastic properties) that will liquefy or is preferably made by this material, and wherein the coil of stitching thread 4 (for example remains in the system 25 of the passage that is arranged in the spud 22 and/or groove, as directed, constituted by common eyelet 85).Be in simple reason, stitching thread 4 is only shown in the final stage (d) of Fig. 1.

When anchor shown in Figure 1 used in conjunction with the K line, vibration tool 1 and spud 22 comprised that be used to the axial passage that holds the K line wherein this passage for example extends along the axle of spud, and described eyelet 85 has eccentric position.

If still will be slidably with respect to anchor at suture anchor 2 fixing back stitching thread 4, then the stitching thread terminal part preferably passes thermoplasticity sleeve 23 or passes vibration tool 1 and extend, and can comprise the axial passage that passes its distal portion at least at this purpose vibration tool.When stitching thread 4 is fixed together with anchor with respect to anchor is locked, the stitching thread terminal part preferably extends in the outside of thermoplasticity sleeve 23, wherein, enter during sclerous tissues's process sutural infringement in order to prevent from ordering about spud 22, can axial suture trough (not shown) (also referring to Fig. 4) be set at the thermoplasticity sleeve.As shown in Figure 1, vibration tool 1 can be passed the whole length of thermoplasticity sleeve 23.Alternately, spud 22 can enter or pass thermoplasticity sleeve 23 and comprise in this proximal region possibly for keeping sutural device (for example, eyelet).

The stage of Fig. 1 (a) shows suture anchor 2 on the instrument of being installed in 1 far-end, be connected to the spud 22 of distal tool end and be seated in spud 22 proximal side (or be attached to spud 22 proximal side, referring to Fig. 4) and loosely around the thermoplasticity sleeve 23 of distal tool end (or nearside spud parts).Connection between spud 22 and the distal tool end makes and can will point to the power (propulsive force or compression stress) in the sclerous tissues and guide the power (traction force or tension force) of leaving sclerous tissues to be passed to spud 22, thereby make vibration be passed to spud from instrument, and make instrument 1 after fixation procedure is finished, easily to separate from spud 22.Suitable connection for example is the inboard of bayonet coupling, combination and outside screw, maybe may is to be suitable for broken predetermined breakaway poing by instrument after with respect to the anchor rotation.There is not this connection of end-play can transmit this vibration fully.This connection with end-play particularly has the bayonet coupling of end-play, can but only can transmit half vibration wave (impact effect in application of force step).If this connection designed to be able to revolving force is passed to spud 22 from instrument 1, then application of force process not only can strengthen by vibration, can also strengthen by the rotation of spud 22.

Except anchor 2(spud 22 and thermoplasticity sleeve 23) and vibration tool 1, the equipment of be used for carrying out according to the method for Fig. 1 also comprises support member 80, it has tubular part 81 and fits into opening 5.1 and allow the distal tool end to pass it being used for.The cross section of tubular part 81 is identical with the cross section of spud 22 or preferably smaller, thus make it not the application of force the or seldom application of force enter by ordering about spud enter in sclerous tissues's opening that sclerous tissues produces.Support member 80 preferably also comprises flange-shape parts 82, and it allows support member to be seated on the sclerous tissues surface, and wherein tubular part 81 extends in the opening 5.1.Support member can be used to guiding vibration tool and be attached to the parts of the guiding instrument (not shown) of vibration source (not shown), and the near-end of vibration tool is coupled to vibration source or is coupled to its shell.At anchoring under the cortex of suture anchor 2 (or any anchoring in the subsurface desired depth of sclerous tissues), the tubular part 81 of support member 80 has correspondence near the axial length of the thickness (or desired depth) of cortical bone layer 7.At the anchoring in other degree of depth of sclerous tissues, tubular part 81 can be longer or shorter or can not be had (referring to Fig. 2) substantially.In order to allow the surgeon determine optimum depth at anchoring, support member 80 can not comprise flange-shape parts 82, or the latter can be made of ring, and the axial location of this ring on tubular part 81 can be regulated by the surgeon.

Stage (b) shows by applying propulsive force F.1 and preferably vibrating V to vibration tool 1 and ordered about the suture anchor that enters behind the spongy bone 8, and wherein employed vibration can comprise the vibration mode of Modulation and Amplitude Modulation or pulse as discussed above.During application of force step, the material of thermoplasticity sleeve liquefaction is by using this vibration mode to be prevented from, and also can be prevented from by guaranteeing that thermoplasticity sleeve 23 is not clamped between supporting member 80 and the spud 22.When the flange-shape parts 82 of supporting member 80 can begin to contact with sclerous tissues surface 6, spud 22 had reached enough degree of depth in spongy bone.

Stage, (c) showed the anchor after the anchoring step, it is realized as follows: by vibrating described instrument 1(vibration V, in that can to use when being different from the application of force step employed vibration mode be the vibration of foundation) and apply traction force F.2 to instrument 1, and by keeping support member 80(or corresponding guiding instrument, support member is the part of guiding instrument) against the sclerous tissues surface (power F.3) resist traction force F.2, namely apply pressure to thermoplasticity sleeve 23 or it be clamped in respectively between spud 22 and the support member 80.Because thermoplasticity sleeve 23 is clamped between spud 22 and the support member 80 so also because vibration, the material of thermoplasticity sleeve begins to liquefy at least in part from its proximal side and/or distal face according to the energy drag device on these end faces that provide to act on thermoplasticity sleeve 23, and these liquefied material infiltrations are around the sclerous tissues of thermoplasticity sleeve 23.Liquefaction and displacement by bush material make the thermoplasticity sleeve become shorter, support member 80 is held against the sclerous tissues surface, and spud 22 is mobile in the direction against the sclerous tissues surface in sclerous tissues, stay the space, bottom 5.2 of opening 5, it is set up in application of force step or enlarges at least.

Stage (d) shows final fixing suture anchor 2, and instrument 1 separates from spud 22, and instrument 1 and support member 80 remove from fixed position.

Certainly can also after finishing, the anchoring step not remove support member 80, wherein advantageously match the support member 80 or material of the material of its extremity and thermoplasticity sleeve 23 or its contact surface is so that during the anchoring step at least, support member 80 is by welding or be bonded to thermoplasticity sleeve 23 or be fixed to thermoplasticity sleeve 23 by being connected fully between the two.The support member that remains on fixed position is used in stitching thread and for example prevents when bone surface 6 is strained that stitching thread 4 from being damaged by the edge of cortical bone or other sclerous tissueses at the opening part of bone opening 5.1.

Depend on the quality of sclerous tissues hardly by means of the anchoring of the original position of the material with thermoplastic properties liquefaction, sclerous tissues even can be non-existent fully (soft tissue under the cortical bone layer or main cavity) in according to the embodiment of Fig. 1.In latter's situation, permeable or the inner surface that can impermeable cortical bone layer of liquefied material also remains in sclerous tissues's opening 5.1, and this is mainly by constituting the fact that no longer can pass the main body of opening behind resolidification.This means according to fixing under the fixing cortex that not only is suitable in the spongy bone that mechanical stability reduces of the present invention, when also being used for not having spongy bone, for example in the medullary cavity of long bone or on the noncontact side of hone lamella or exceed hone lamella and fix (it is fixing to knot by cortex).

Above the exemplary application that knots on the mentioned cortex for example about the human body shoulder: acute acromioclavicular joint is stable; And about the human foot: syndesmosis fracture fixing.In above-mentioned application, can be to sew up bundle by the fixing stitching thread that knots on the cortex, it is used for directly substituting tendon or ligament.

Described at the open text WO2009/109057 of quote, advantageously make equipment assembling shown in Figure 1 with automatic more method, it is by providing layout with fastening means 1, anchor 2 and support member 80(or corresponding guiding instrument) the pretension elastic component (for example, the pretension spring) forms the enclosed load framework, the size of described elastic component and pretension thereof is designed to be provided for thermoplasticity sleeve 23 is clamped in chucking power between spud 22 and the support member 80, and is used for becoming at thermoplasticity sleeve 23 and drives motion to axial between spud 22 and the support member 80 more in short-term.

Fig. 2 shows another illustrative embodiments of the method according to this invention, wherein said equipment (vibration tool 1, spud 22, thermoplasticity sleeve 23 and support member 80) is shown in the application of force and anchoring step finish after but before instrument 1 and support member 80 remove.The difference of method shown in Figure 2 and method shown in Figure 1 only is that it does not cause the proximal side of thermoplasticity sleeve 23 (for example to be positioned at sclerous tissues subsurface desired depth place, big inner surface place about the cortical bone layer), but in anchored, the proximal side of thermoplasticity sleeve finally approximately flushes with bone surface 6.This anchoring realizes by using the support member 80 do not have tube substantially, and preferably by control anchoring step so that the material of thermoplasticity sleeve 23 mainly begins liquefaction from its far-end.The stitching thread that does not illustrate among Fig. 2 preferably extends through thermoplasticity sleeve 23 and support member 80, and has prevented the infringement that the friction on the bone of the outlet by the bone opening causes by thermoplasticity sleeve 23 thus.

Fig. 3 to 6 shows other illustrative embodiments of anchor or equipment, it comprises anchor 2, instrument 1 and possible support member 80, these equipment are suitable for the method shown in Fig. 1 or 2, and wherein the feature of the feature of these anchors and equipment and the anchor shown in Fig. 1 and 2 and equipment also can being used in combination with combination shown in being different from.

Assembling is used for the liquefaction that the material of thermoplasticity sleeve 23 begins from the nearside sleeve section according to the equipment of Fig. 3, and it is preferably according to the method for Fig. 1.This distal face by support member 80 is gradually reduced to relatively the inner edge 83 of point and realizes, described inner edge has strengthened the displacement of liquefied material outward radial as energy drag device and this taper and gone forward side by side in the bone wall of opening to the marrow.The liquefaction of the distal face of thermoplasticity sleeve can be by not providing the energy drag device to stop (contact area between spud 22 and the thermoplasticity sleeve 23 is big as much as possible and level and smooth) and/or stoping by thermoplasticity sleeve 23 is fixed to spud 22 there.This can pass through in the respective sleeve that far-end with thermoplasticity sleeve 23 is seated in spud 22 as shown in Figure 3 and for example remain there to realize by pressure fitted or frictional fit.The all right following realization of same effect, for example by gummed, welding or these two anchor parts are screwed in together or by spud 22 and thermoplasticity sleeve 23 are fabricated to single piece (also referring to Fig. 4), described single piece for example is manufactured from the same material, and it can be enhanced at application of force step by suitable filler or metal insert in the zone of distally grappling foot.

Fig. 3 also shows the vibration tool that is equipped with stop part 1.1, and described stop part is used for the restriction spud can be ordered about the degree of depth that enters osseous tissue.This stop part 1.1 for example by separation have the axial passage that is adapted to thermoplasticity sleeve 23 the cross section distal tool portion and have the step that can not be introduced into the more heavy in section nearside tool part in the thermoplasticity sleeve and constitute.Wherein, in order to stop thermoplasticity sleeve 23 not expecting when application of force step finishes to liquefy, should be noted that the size of the axial length of distal tool portion, make and come be used to the thermoplasticity sleeve that is in its original greatest length can loosely be seated between spud 22 and the support member 80 having enough spaces between stop part 1.1 and the spud 22.Except the above-mentioned means that are used for preventing the liquefaction do not expected during the application of force step or alternative it, can the vibration mode of correspondingly selecting application of force step as described above.

As mentioned above, can comprise be used to the axial passage that holds the K line according to the equipment of Fig. 2 and according to the anchor (or any other anchor hereinafter described) of Fig. 3, wherein said anchor need be designed so that when passing anchor along the K line this line can not disturb the stitching thread that passes spud or therefrom extend.

Fig. 4 shows single piece anchor 2, and it has the each several part that constitutes spud 22 and thermoplasticity sleeve 23.The coil of stitching thread 4 remains on (or system of other suitable passages and/or groove) in the eyelet 85 that is arranged in the grappling foot 22.Be damaged when entering in the sclerous tissues and/or during the anchoring step, be damaged by vibration or liquefied material in order to prevent that stitching thread 4 from being ordered about at anchor, axial suture trough 86 can be set in thermoplasticity sleeve part 23.Can be only made by a kind of material of the poly-lactic acid material of for example suitable filling according to the anchor of Fig. 4, wherein grappling foot 22 compares with thermoplasticity sleeve part 23 and can be filled to higher degree.Alternately, than the material with thermoplastic properties of thermoplasticity sleeve part, (for example referring to above-mentioned) made by the different materials that is suitable for application of force step by grappling foot.The layout of stitching thread 4 can make it possible to during the application of force and possibly keeping stitching thread with respect to anchor slidably or be used for during the anchoring step with respect to anchor locking stitching thread after the anchoring step.

Fig. 5 shows for the spud 22 that keeps stitching thread 4 and comprises eyelet 85 and a pair of axial suture trough 86, it extends to the proximal side (system of passage and/or groove) of spud from eyelet, and stitching thread 4 can extend or (as shown in Figure 4) can be provided or not provide the outer surface of suture trough to extend along the thermoplasticity sleeve at the inboard (not shown) of thermoplasticity sleeve.In order to be attached to the distal tool end, comprise threaded post according to the spud 22 of Fig. 5, it is adapted to the corresponding female thread that arranges at distal tool face (not shown).

Fig. 6 shows anchor 2, its assembling is used for sewing up the groove that toe-in 4.1 remains on the porch that is arranged at eyelet 85, stitching thread 4 passes eyelet 85 from sewing up toe-in 4.1, extends the proximal side that arrives spud 22 suture trough 86, and then along slit 87(or groove) extend to proximal side from the distal face of thermoplasticity sleeve 23.Anyly can be applicable to the present invention for other known methods that stitching thread remained on spud.

Fig. 7 shows another illustrative embodiments of four successive stages (a) to (d) that an anchor 2 is fixedly arranged of the method according to this invention, wherein there is an anchor with software component 90(for example for example to be suitable for use in, ligament or tendon) or corresponding prosthese spare be fixed to sclerous tissues's (for example, bone).Soft tissue 90 is shown as and is fixed to osseous tissue, and described osseous tissue does not for example have cortical layer (osseous tissue that decorticates, namely cancellous bone tissue 8 only) basically or has can order about the cortical layer that an anchor passes, and distally anchor end for example shape is bored as bone.Anchor 2 still comprise thermoplasticity sleeve 23 and as the top spud 22 that is used for application of force step in conjunction with the described assembling of Fig. 1 to 6, wherein thermoplasticity sleeve 23 has the flange-shape proximal portion, it constitutes anchor head 91, and is formed in the equivalent that is equivalent in the anchoring step according to the flange-shape parts of the support member of Fig. 1.Anchor head 91 is preferably by making with thermoplasticity sleeve 23 identical materials, but also can be made by different materials.Anchor head 91 can comprise in known manner that the distally is outstanding 92, and it is pressed in fixation procedure and enters in the soft tissue 90.

Four-stage shown in Figure 7 (a) to (d) is basic identical to (d) with four-stage (a) shown in Figure 1, and therefore only explains the difference with the latter hereinafter.

At stage (b), anchor 2 is illustrated as anchor to be ordered about and is entered in the sclerous tissues enough degree of depth, can press soft tissue 90 in anchor head 91 and be pressed so that the distally of anchor head 91 outstanding 92 is pressed against in the soft tissue or even realize entering enough degree of depth when passing soft tissue and may enter in the bone surface 6 against bone surface 6 and soft tissue 90.Stage (d) has shown an anchor 2 and finally has been anchored in the cancellous bone tissue 8, and soft tissue 90 is attached to osseous tissue safely thus.

If comprise that according to the anchor 2 of Fig. 7 being used for as shown in earlier drawings and Fig. 8 keep sutural device, it can certainly be used for stitching thread is fixedly replaced for soft tissue is fixed with respect to osseous tissue with respect to osseous tissue.

Necessaryly in the embodiment of as shown in Figure 7 the method according to this invention be, and in embodiment shown in Figure 2 preferably, liquefaction process begins at the far-end of thermoplasticity sleeve, and the therefore contact area assembling energy drag device between the proximal side of the distal face of thermoplasticity sleeve 23 and spud 22 advantageously.Fig. 8 shows the preferred implementation of this energy drag device, its proximal side with spud 22 inwards phases down to form the form of relative sharp edges 83, sharp edges 83 is adapted to pass the cross section of the axial passage of thermoplasticity sleeve 23, wherein relatively sharp edges 83 constitutes the energy drag devices and this taper has strengthened the displacement of liquefied material outward radial, and enters in the osseous tissue of anchor stiffener or the reinforce of the tissue of spud (finally around) thus.In addition, Fig. 8 shows groove, is preferably the otch groove, and it is arranged in the taper proximal side of spud 22, and it will be filled with liquefied material to be connected fully spud 22 is connected to thermoplasticity sleeve 23 in final mooring anchor during the anchoring step.Further illustrate as Fig. 9, stage (c) illustrates the similar anchor in the anchoring structure, the described design of nearside grappling instep also helps spud stable against each load, described load can be tilted or the described spud of transversion malposition with the certain angle effect of anchor axle and especially in having the sclerous tissues of less mechanical resistance.

Fig. 9 shows another illustrative embodiments of the method according to this invention, wherein said anchor can be with according to the similar type (stitching thread is only shown in the stage (c)) of the anchor of Fig. 8 and can comprise head or do not have head, maybe can be that an anchor is arranged.As described above, spud is ordered about to enter in the osseous tissue and during the anchoring step in application of force step remains on same position, the material of thermoplasticity sleeve preferably begins liquefaction from the far-end of thermoplasticity sleeve, and the design according to described anchor, support member 80 or anchor head 91 be towards 22 motions of static spud, and F.2 and/or possibly the power that is used for this motion F.3 preferably by resisting by the osseous tissue that contact with the distal face of spud with the tension force that is applied to vibration tool 1.

Fig. 9 shows this method with three successive stages (a) to (c).Stage (a) shows the equipment for this method of execution, and it is positioned in the pilot hole 5.4 that is arranged in the osseous tissue.With top described the same at other embodiments of the present invention, anchor 2 comprises and is suitable for being ordered about spud 22 and the thermoplasticity sleeve 23 that enters in the sclerous tissues that wherein said thermoplasticity sleeve 23 can comprise that flange-shape proximal portion (anchor head 91) or this equipment also comprise support member 80.Far-end and thermoplasticity sleeve 23 that spud 22 is fixed to vibration tool 1 loosely are seated on the proximal side of spud 22.Stage (b) shows the anchor after the application of force step, wherein by means of act on by vibration tool 1 on the spud 22 propulsive force F.1, anchor is ordered about to be entered in the pilot hole 5.4, pilot hole 5.4 is extended about cross section and/or the degree of depth thus.Also shown in the stage (b), in the anchoring step, F.3, anchor head 91 or support member 80 move towards spud 22 by means of the power that is applied to anchor head or support member, and F.2 and/or by the osseous tissue in the distal face zone of spud its traction force that is applied on vibration tool 1 is resisted, and wherein the size of these power makes spud keep static substantially with respect to osseous tissue.Stage (c) illustrates application of force step and fastening step finish after and remove mooring anchor after the vibration tool 1.

Figure 10 shows the anchor 2 that is suitable for the method according to this invention, and described anchor comprises spud 22, and its assembling is entered sclerous tissues for ordering about by puncture sclerous tissues, and piercing process is preferably by means of the aforesaid vibrational energy that is coupled to spud 22.Spud shown in Figure 10 is suitable for all embodiments of aforesaid the method according to this invention.It is particularly suitable for being ordered about passes in the tissue that cortical bone layer 7 enters cortical bone layer below, its can be compacted with the hold bone cortical layer pass lamella (for example, cancellous bone tissue 8), or enter in the cavity or soft tissue of cortical bone layer 7 below.Figure 10 shows the method embodiment that is similar to method shown in Figure 1, wherein spud 22 be depicted as at (stage (b)) between puncture step (stage (a)), puncture step and the anchoring step and after the anchoring step location of (stage (c)).Can be in conjunction with being used for keeping sutural any passage and/or tank systems to use and/or described having an anchor to use in the above according to the spud 22 of Figure 10.

Comprise far-end with hollow cylinder (circular or non-circular) form according to the spud 22 of Figure 10, it has thin-walled and sharp-pointed distal face, at puncturing (application of force step) and being installed at the anchoring step on the far-end of vibration tool 1, wherein thermoplasticity sleeve 23 is seated between spud 22 and the opposition element 80.At the puncture step, spud 22 for example is positioned on the cortical bone layer 7 that will realize in the zone fixing under the cortex of spud 22 (stage (a)).By means of instrument 1 be passed to the vibration of spud 22 by instrument 1, spud 22 is ordered about to be entered in the osseous tissue, its its lamella that punctures out step displacement of going forward side by side enters the cancellous bone tissue 8 that is arranged in cortical bone layer 7 below, and compresses the described cancellous bone tissue 8(stage (b) simultaneously).When having passed cortical bone layer 7, spud 22 has arrived enough degree of depth in the osseous tissue in liquefaction position (for example, the contact surface between the proximal side of the distal face of counterpart 80 and thermoplasticity sleeve 23).In case anchor arrives this final position, the power on the instrument 1 of acting on is reversed (namely from progradation to traction action), and when thermoplasticity sleeve 23 at least part of being liquefied, spud 22 is pulled against the cortical bone layer, and the liquefaction bush material is anchored at spud 22 (resolidification material 40) on the inboard of cortical bone layer 7 or forms the main body 44 of opening that can not be by puncture cortical bone layer.

Embodiments of the present invention recited above relate to the suture anchor of the soft tissue that is suitable for being attached to sclerous tissues especially.In described all embodiments for the method that this suture anchor is fixed on sclerous tissues, stitching thread can by preferably pass be positioned at sclerous tissues's opening before suture anchor or its part or with suture anchor before and have the material liquefaction of thermoplastic properties necessarily before prevent the heat infringement of being distributed from the material with thermoplastic properties when soaking in liquefaction with liquid (water or normal saline).

In the above description, a plurality of embodiment of the present invention is described to have special characteristic.Know that above-described those skilled in the art can easily change into suitable some in these features the some other feature in each embodiment, and they are added into these other embodiments, or use them to replace at the described feature of these other embodiments.Equally, know that above-described those skilled in the art can easily make the appropriate combination of the suitable characteristics of shown in the present and the embodiment of describing.

Claims

One kind by means of the liquefaction of the original position of the material with thermoplastic properties with suture anchor (2) or there is head to be anchored on equipment in the sclerous tissues, this equipment comprises:

Spud (22), it has far-end, and assembling is used for being ordered about entering or pass sclerous tissues; Instrument (1), it has the far-end that connection maybe can be connected to the near-end of described spud (22); And thermoplasticity sleeve (23), it comprises described material with thermoplastic properties;

Wherein said thermoplasticity sleeve (23) is suitable for being seated on the proximal side of described spud (22), and the proximal portion of described instrument (1) or described spud (22) extends through described thermoplasticity sleeve (23); And

Connection between the far-end of wherein said instrument (1) and the described spud (22) can separate, and assembling is used for and pressure and tension force and mechanical vibration can be passed to described spud (22) from described instrument (1).
2. equipment according to claim 1, this equipment also comprises support member (80), and described support member (80) is seated on the proximal side of described thermoplasticity sleeve (23), and wherein said instrument (1) extends through described support member (80).
3. equipment according to claim 1, wherein said thermoplasticity sleeve (23) comprise the proximal flange that constitutes anchor head (91).
4. according to each described equipment among the claim 1-3, this equipment is the involving vibrations source also, and the proximal end coupling of described instrument (1) maybe can be coupled to described vibration source.
5. equipment according to claim 4, wherein said vibration source can optionally produce two kinds of different vibration modes.
6. equipment according to claim 5, first kind of pattern in wherein said two kinds of different vibration modes is amplitude-modulated or comprises pulse.
7. according to each described equipment among the claim 1-6, the distal face of the proximal side of wherein said spud (22) and/or described support member (80) comprises the structure as the energy drag device.
8. according to each described equipment among the claim 1-7, the distal face of the proximal side of wherein said spud (22) and/or described support member (80) comprises the otch groove.
9. according to each described equipment among the claim 1-8, wherein said spud (22) comprises for the passage of the coil that keeps stitching thread (4) and/or the system (25) of groove.
10. equipment according to claim 9, wherein said thermoplasticity sleeve (23) comprises be used at least one axial groove or the slit that hold described stitching thread (4).
11. equipment according to claim 9, wherein said stitching thread (4) passes described thermoplasticity sleeve (23).
12. according to each described equipment among the claim 1-11, the far-end of wherein said spud (22) fitted to be Centesis instrument.
13. one kind by means of the liquefaction of the original position of the material with thermoplastic properties with suture anchor or there is head to be anchored on method in the sclerous tissues, this method may further comprise the steps:

Provide according to each described equipment among the claim 1-12;

Order about and enter in the described sclerous tissues by vibration tool (1) being applied spud (22) that propulsive force will be connected to the far-end of described vibration tool (1);

By vibrating described instrument and applying pressure to described thermoplasticity sleeve (23) anchor (2) is anchored in the described sclerous tissues, simultaneously described spud (22) is remained in the same position or towards the direction motion on sclerous tissues surface to be used for described original position liquefaction with material of thermoplastic properties;

Stop to vibrate described instrument and described instrument is separated and described instrument (1) is removed from described spud from described spud (22).
14. method according to claim 13 wherein, in application of force step, is vibrated described instrument (1) also and then is vibrated described spud (22).
15. method according to claim 14 wherein, in described application of force step, is used first vibration mode, and wherein, in the anchoring step, uses second vibration mode that is different from described first vibration mode.
16. method according to claim 15, wherein said first vibration mode comprises Modulation and Amplitude Modulation or pulse.
17. according to each described method among the claim 13-16, wherein for described thermoplasticity sleeve (23) is exerted pressure, propulsive force (F.3) is applied to described thermoplasticity sleeve (23) or support member (80).
18. method according to claim 17, wherein said propulsive force (F.3) are applied the traction force (F.2) on described instrument (1) and/or are resisted by the sclerous tissues in the zone of the distal face of described spud (22).
19. according to each described method among the claim 13-18, wherein, before described application of force step, in described sclerous tissues, opening is set, and wherein, in described application of force step, described spud (22) is ordered about to be entered in the described opening, and described opening is extended about cross section and/or the degree of depth.
20. according to each described method among the claim 13-18, wherein, before described application of force step, described spud (22) is positioned in that sclerous tissues surface (6) goes up, enters in the pilot hole (5.4) that is arranged in described sclerous tissues surface (6) or is passing the opening (5.1) that is arranged in the cortical bone layer (7) above the cancellous bone tissue.